FDA Reform Still On Hold
It has been almost two years since Congress was asked to consider implementing stronger drug safety procedures. The proposed changes would include reforming the FDA’s handling of Vioxx and other heavily marketed pain medications that studies have linked to deaths, heart attacks and strokes.
It has been reported that Congress has refused to consider any of the proposals to reform the FDA due to the fact that congressional members are too comfortably involved with the pharmaceutical industry.
Drug giant Merck, maker of Vioxx, pulled the painkiller from the market in 2004. Shortly thereafter, the FDA ordered Pfizer to withdraw its arthritis medicine Bextra, requiring that more warnings be put on the pain pills.
Reform of the manner in which the FDA approves and distributes new drugs to the public is crucial. In 2005 a public hearing was held to create an independent drug safety center within the FDA. Under this bill, if a drug turned out to have safety problems the center could restrict distribution, require labeling changes or even withdraw its approval.
A Wall Street Journal Online/Harris Interactive poll released in May 2006 revealed that on 36 percent of the public thinks the FDA is doing a good job, down from 56 percent in 2004. The poll also found that 80 percent of the public has concerns about the FDA’s ability to make independent decisions regarding the safety of medications.
The pharmaceutical industry, in response to deteriorating levels of public confidence, has adopted voluntary guidelines for direct-to-consumers advertisements of prescription drugs. Further to this effort Bristol-Myers Squibb recently imposed a ban on advertising its drugs to consumers during their first year on the market.
The spotlight needs to remain on the weaknesses in the FDA that have already caused tens of thousands of people to die needlessly because of inadequately tested drugs that are too aggressively advertised.